Olema is a biotechnology company in the preclinical stage that specializes in creating new drugs for the treatment and prevention of estrogen receptor (ER) positive breast cancer. The company's primary focus is on the discovery, development, and commercialization of targeted therapies designed specifically for women's cancers. By utilizing their extensive knowledge of the molecular action of the ER, Olema aims to create compounds that surpass the effectiveness of both current and developing drugs. With a deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance, Olema is dedicated to transforming the standard of care for pre- and post-menopausal women living with cancer by developing more convenient and effective therapies.

Tags

Skin and Musculoskeletal Diseases

Urogenital Diseases

Neoplasms

Small molecule drug

Chemical drugs

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	4
Endocrinology and Metabolic Disease	2
Nervous System Diseases	2
Hemic and Lymphatic Diseases	2
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3
Chemical drugs	1

Top 5 Target	Count

CDK4 x CDK6	1
ER(Estrogen receptors)	1
PI3Kα(Phosphatidylinositol 3 kinase alpha)	1
KAT6A x KAT6B	1

Drugs associated with Olema Pharmaceuticals, Inc.

Alpelisib

Target

PI3Kα

Mechanism

PI3Kα inhibitors

Active Org.

Novartis Pharmaceuticals Corp. [+9]

Originator Org.

Novartis Pharma AG

Active Indication

Inactive Indication

Adenocarcinoma of Lung [+26]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date24 May 2019

Palbociclib

Target

CDK4 x CDK6

Mechanism

CDK4 inhibitors [+1]

Active Org.

National Cancer Institute [+17]

Originator Org.

Pfizer Inc.

Active Indication

Metastatic breast cancer [+108]

Inactive Indication

acute leukemia [+43]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date03 Feb 2015

Palazestrant

Target

Mechanism

ERs antagonists

Active Org.

Olema Pharmaceuticals, Inc.

Originator Org.

Olema Pharmaceuticals, Inc.

Active Indication

ER-positive/HER2-negative Breast Cancer [+8]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Olema Pharmaceuticals, Inc.

NCT06016738 / RecruitingPhase 3

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Start Date16 Nov 2023

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

NCT05508906 / RecruitingPhase 1

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Treatment Group 3: OP-1250 in combination with everolimus.

Start Date31 Aug 2022

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

[+1]

ACTRN12621001419853 / RecruitingPhase 1

A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

Start Date03 Feb 2022

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

100 Clinical Results associated with Olema Pharmaceuticals, Inc.

0 Patents (Medical) associated with Olema Pharmaceuticals, Inc.

Literatures (Medical) associated with Olema Pharmaceuticals, Inc.

04 Mar 2024·Molecular Cancer Therapeutics

Palazestrant (OP-1250), A Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination

Article

Author: Palanisamy, Gopinath S ; Parisian, Alison D ; Myles, David C ; Peña, Guadalupe ; Robello, Brandon ; Barratt, Susanna A ; Sun, Richard ; Kulp, David ; Hodges-Gallagher, Leslie ; Harmon, Cyrus L ; Sapugay, Judevin ; Kushner, Peter J ; Ortega, Fabian E

AbstractThe estrogen receptor (ER) is a well-established target for the treatment of breast cancer, with the majority of patients presenting as ER-positive (ER+). Endocrine therapy is a mainstay of breast cancer treatment but the development of resistance mutations in response to aromatase inhibitors, poor pharmacokinetic properties of fulvestrant, agonist activity of tamoxifen, and limited benefit for elacestrant leave unmet needs for patients with or without resistance mutations in ESR1, the gene that encodes the ER protein. Here we describe palazestrant (OP-1250), a novel, orally bioavailable complete ER antagonist and selective ER degrader. OP-1250, like fulvestrant, has no agonist activity on the ER and completely blocks estrogen-induced transcriptional activity. In addition, OP-1250 demonstrates favorable biochemical binding affinity, ER degradation, and antiproliferative activity in ER+ breast cancer models that is comparable or superior to other agents of interest. OP-1250 has superior pharmacokinetic properties relative to fulvestrant, including oral bioavailability and brain penetrance, as well as superior performance in wild-type and ESR1-mutant breast cancer xenograft studies. OP-1250 combines well with cyclin-dependent kinase 4 and 6 inhibitors in xenograft studies of ER+ breast cancer models and effectively shrinks intracranially implanted tumors, resulting in prolonged animal survival. With demonstrated preclinical efficacy exceeding fulvestrant in wild-type models, elacestrant in ESR1-mutant models, and tamoxifen in intracranial xenografts, OP-1250 has the potential to benefit patients with ER+ breast cancer.

01 Mar 2023·Cancer Research

Abstract P2-24-07: Combination of complete estrogen receptor antagonist, OP-1250, and CDK4/6 inhibitors enhances tumor suppression and inhibition of cell cycle-related gene expression

Author: Parisian, Alison D. ; Ortega, Fabian ; Harmon, Cyrus ; Sapugay, Judevin L. ; Palanisamy, Gopinath S. ; Kulp, David ; Bodell, William J. ; Kushner, Peter

AbstractOP-1250, a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD), is currently in Phase I/II clinical trials for the treatment of estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. OP-1250 has previously demonstrated efficacy in both estrogen receptor 1 (ESR1) wild-type and Y537S mutant breast cancer xenograft models. Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) are a standard first-line treatment for ER+ advanced or metastatic breast cancer in combination with endocrine therapy. To characterize OP-1250 efficacy in this setting, we explored the combination of OP-1250 with CDK4/6 inhibitors palbociclib and ribociclib in ER+/HER2- breast cancer preclinical models, and profiled the transcriptional changes associated with single agent and combination therapy. OP-1250 and CDK4/6 inhibitors were tested alone and in combination in ESR1 wild-type MCF7 and ESR1 Y537S mutant ST941 xenograft models. Higher doses of OP-1250 and either CDK4/6 inhibitor, when given as a monotherapy, suppress tumor growth and increase animal survival, while lower doses of the compounds display a modest or minimal effect on tumor growth or survival. In combination, lower doses of OP-1250 and either CDK4/6 inhibitor result in significantly greater tumor growth suppression (both xenograft models), tumor regression (MCF7) and animal survival (ST491) than each compound individually. RNA sequencing revealed substantially more gene expression changes with combination treatment than monotherapy. In particular, pathways associated with cell cycle progression displayed greater changes with combination treatment, similar to what was observed with a much higher dose of monotherapy. This study supports the clinical evaluation of OP-1250 in combination with CDK4/6 inhibitors (palbociclib or ribociclib) and provides additional context to mechanisms of combination efficacy. OP-1250 is currently being evaluated in a Phase Ib clinical trial in combination with palbociclib and a study including evaluation of the combination of OP-1250 with ribociclib is planned to initiate in Q3 2022.Citation Format: Alison D. Parisian, Gopinath S. Palanisamy, Fabian Ortega, Judevin L. Sapugay, William J. Bodell, David Kulp, Peter Kushner, Cyrus Harmon. Combination of complete estrogen receptor antagonist, OP-1250, and CDK4/6 inhibitors enhances tumor suppression and inhibition of cell cycle-related gene expression [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-24-07.

15 Feb 2021·Cancer Research

Abstract PS18-16: The complete estrogen receptor antagonist OP-1250 shrinks tumors in xenograft models and has favorable preclinical pharmacokinetic attributes

Author: Klein, Pamela M ; Kushner, Peter J ; Zujewski, Jo Anne ; Hodges-Gallagher, Leslie ; Harmon, Cyrus L ; Myles, David C ; Sun, Richard

AbstractAntiestrogens are widely used to treat ER+, HER2- breast cancer however these may produce estrogen-like agonist effects in a cell and gene-specific manner. Furthermore, this partial agonism has been implicated in the development of tumor resistance. In contrast, a complete ER antagonist lacks agonist activity in all tissues. Given the high risk of recurrence in ER+ patients treated with endocrine therapies, we hypothesize that drugs that completely antagonize ER-mediated signaling will have a clinical advantage in treating resistant tumors, particularly in tumors for which the ER has acquired mutations conferring estrogen-independent growth.We previously identified OP-1250 in our laboratory as a complete antagonist and degrader of wild type and mutant ERalpha in breast and uterus cells. Here we explore the pharmacokinetic properties of orally administered OP-1250 and its ability to shrink breast tumors from xenograft models expressing both wild type and mutant estrogen receptors. Orally administered OP-1250 produced high and stable levels in multiple species, suggesting that once daily dosing may be sufficient to produce excellent drug exposure in patients. OP-1250 shrank ER+ tumors in multiple patient-derived tumor xenografts in mice at daily doses of 3 mg/kg, including in tumors expressing the Y537S allele of ERalpha that confers estrogen-independent growth and tumor resistance. Furthermore, OP-1250 accumulated within tumor specimens, indicating excellent target penetration was achieved with low daily doses.These preclinical studies indicate that OP-1250 has the potential to be a best-in-class antiestrogen due to its ability to complete antagonize ER, potent efficacy in shrinking tumors, and robust drug exposure. A Phase 1/2 dose escalation and expansion study in patients with ER+, HER2- metastatic or advanced BC previously treated with an endocrine therapy will be initiated this year.Citation Format: Leslie Hodges-Gallagher, Richard Sun, David C Myles, Pamela M Klein, Jo Anne Zujewski, Cyrus L Harmon, Peter J Kushner. The complete estrogen receptor antagonist OP-1250 shrinks tumors in xenograft models and has favorable preclinical pharmacokinetic attributes [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS18-16.

News (Medical) associated with Olema Pharmaceuticals, Inc.

23 Oct 2024

·www.globenewswire.com

Olema Oncology Presents Compelling New Preclinical Data Demonstrating Anti-Tumor Activity for OP-3136 with Enhanced Activity of Palazestrant Combinations at ENA 2024

OP-3136, a potent KAT6 inhibitor, demonstrated robust anti-tumor activity as a single agent, as well as synergy and enhanced anti-tumor activity in combination with palazestrant; IND submission expected before year endPalazestrant demonstrated combinability and enhanced tumor suppression with both everolimus and capivasertib SAN FRANCISCO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced results from three preclinical studies that will be presented during poster sessions at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in Barcelona, Spain. “Building on our earlier studies that showed compelling single agent activity for OP-3136, this new data demonstrates the potential for OP-3136 in combination with palazestrant, with strong tumor growth inhibition and regression relative to combinations with fulvestrant,” said David C. Myles, Ph.D., Chief Discovery and Non-Clinical Development Officer of Olema Oncology. “Taken together, these data reinforce our belief in the potential of OP-3136 as an exciting new therapy for breast and other cancers. We look forward to submitting our Investigational New Drug (IND) application for OP-3136 to the US Food and Drug Administration before the end of this year.” Title: “Combining OP-3136, a KAT6 inhibitor, with endocrine therapy and CDK4/6 inhibitor enhances anti-tumor activity in ER+/HER2- breast cancer models”Abstract: 230Session: 300Date: Thursday, October 24, 2024Time: 9:00 to 17:30 CEST Key findings include: OP-3136 inhibited cell proliferation and synergized with anti-estrogens (fulvestrant and palazestrant) and a CDK4/6 inhibitor (ribociclib) in a breast cancer cell line.OP-3136 led to either tumor growth inhibition or tumor regression in vivo in xenograft models across all treatment groups.In combination with OP-3136, palazestrant was consistently superior to fulvestrant and led to improved anti-tumor activity and tumor regression.OP-3136 showed robust synergistic anti‑tumor activity when combined with fulvestrant or palazestrant as doublet therapy in breast cancer models. Dr. Myles continued, “With the potential to become a best-in-class endocrine therapy and improve upon current standard of care treatments for women living with metastatic breast cancer, our lead product candidate, palazestrant, continues to move through the clinic as a monotherapy in our pivotal Phase 3 OPERA-01 trial while also demonstrating combinability with multiple targeted agents, including CDK 4/6 inhibitors, in Phase 1/2 studies. Our preclinical posters at ENA show that the combination of palazestrant with both everolimus and capivasertib are synergistic and result in significant tumor regression. We look forward to advancing the development of palazestrant in combination with everolimus, ribociclib, and other agents and expect to present updated Phase 2 data for palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) this December.” Title: “Combining palazestrant, a CERAN, and everolimus, an mTOR inhibitor, enhances tumor suppression in ER+/HER2- breast cancer models”Abstract: 211Session: 300Date: Thursday, October 24, 2024Time: 9:00 to 17:30 CEST Key findings include: Palazestrant and everolimus demonstrate synergy in vitro and in vivo and resulted in greater anti-proliferative activity than either agent alone.Combining palazestrant with everolimus causes gene signature transcriptional changes, downregulating cell cycle progression and upregulating apoptosis.These data support clinical investigation of the combination of palazestrant and everolimus. Title: “Combining palazestrant, a CERAN, and capivasertib, a pan-AKT inhibitor, enhances tumor suppression in ER+/HER2- breast cancer models”Abstract: 212Session: 300Date: Thursday, October 24, 2024Time: 9:00 to 17:30 CEST Key findings include: Palazestrant and capivasertib work synergistically to inhibit proliferation of multiple ER+ breast cancer models, both in vitro and in vivo.Palazestrant demonstrates superior anti-tumor efficacy over fulvestrant in combination with capivasertib, significantly inhibiting and repressing tumor growth.Combining palazestrant and capivasertib increases downregulation of genes associated with cell cycle progression.These data support clinical investigation of the combination of palazestrant and capivasertib. Copies of these posters are available on the Publications page of Olema’s website. About Palazestrant (OP-1250)Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com. About OP-3136OP-3136 is a novel, orally-available small molecule that potently and selectively inhibits KAT6, an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and CDK4/6 inhibitors. Olema has successfully completed IND-enabling studies in support of a potential Investigational New Drug (IND) application with the FDA and expects to initiate Phase 1 clinical trials for OP-3136 in early 2025. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the timelines for initiation and enrollment for potential clinical studies and for results of clinical trials of palazestrant (OP-1250) as a monotherapy and in combination trials, potential beneficial characteristics, including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant, the potential of palazestrant to advance the standard of care for women living with cancer, palazestrant’s combinability with other drugs, the initiation of a phase 1b/2 clinical study of palazestrant in combination with everolimus and timing thereof, and the sufficiency and timing of Olema’s preclinical program, including the potential beneficial characteristics of its KAT6 inhibitor compounds and the timing of a potential IND application and advancement into clinical development for OP-3136. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. ContactCourtney O’Konek, Vice President, Corporate Communicationsmedia@olema.com

Phase 3Clinical ResultFast TrackPhase 1Phase 2

09 Oct 2024

·www.globenewswire.com

Olema Oncology Announces New Preclinical Combination Data to be Presented at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Poster presentations include new preclinical data demonstrating activity for palazestrant in combination with capivasertib and everolimus, and OP-3136, Olema’s KAT6 inhibitor, in combination with palazestrant and other targeted agentsSAN FRANCISCO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women’s cancers, today announced that it will be presenting multiple posters during the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) taking place October 23-25, 2024, in Barcelona, Spain. Details of the ENA 2024 poster presentations are: Title:Combining palazestrant, a CERAN, and everolimus, an mTOR inhibitor, enhances tumor suppression in ER+/HER2- breast cancer modelsPoster/Abstract:211Session:Poster Session 300, Exhibition HallDate/Time:Thursday, October 24, 2024, from 09:00 to 17:30 CEST Title:Combining palazestrant, a CERAN, and capivasertib, a pan-AKT inhibitor, enhances tumor suppression in ER+/HER2- breast cancer modelsPoster/Abstract:212Session:Poster Session 300, Exhibition HallDate/Time:Thursday, October 24, 2024, from 09:00 to 17:30 CEST Title:Combining OP-3136, a KAT6 inhibitor, with endocrine therapy and CDK4/6 inhibitor enhances anti-tumor activity in ER+/HER2- breast cancer modelsPoster/Abstract:230Session:Poster Session 300, Exhibition HallDate/Time:Thursday, October 24, 2024, from 09:00 to 17:30 CEST Additional information, including abstracts for these presentations, can be found on the ENA website. Copies of the posters will be made available on the Publications page of Olema’s website in alignment with the Symposium’s embargo policy. About Palazestrant (OP-1250)Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Contact:Courtney O’Konek, Vice President, Corporate Communicationsmedia@olema.com

Phase 3Fast Track

21 Aug 2024

·www.globenewswire.com

Olema Oncology to Participate in Morgan Stanley 22nd Annual Global Healthcare Conference

SAN FRANCISCO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women’s cancers, today announced that its management team will participate in the following upcoming investor conference: Morgan Stanley 22nd Annual Global Healthcare ConferenceDate: Wednesday, September 4, 2024, at 7:45 a.m. ETLocation: Marriott Marquis in New York, NYFormat: Fireside Chat A live webcast of the Fireside Chat will be available under the News & Events section of Olema’s investor relations website at ir.olema.com. The webcasts will be archived for at least 30 days. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Contact:Geoffrey Mogilner, Investor Relations and Communicationsir@olema.com

Phase 3

100 Deals associated with Olema Pharmaceuticals, Inc.

100 Translational Medicine associated with Olema Pharmaceuticals, Inc.

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Pipeline Snapshot as of 24 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1 Clinical

Phase 3 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Palazestrant ( ER )	ER-positive/HER2-negative Breast Cancer More	Phase 3
Palbociclib ( CDK4 x CDK6 )	Hormone receptor positive HER2 negative breast cancer More	Phase 1
Alpelisib ( PI3Kα )	HER2-negative breast cancer More	Phase 1
OP-3136 ( KAT6A x KAT6B )	Castration-Resistant Prostatic Cancer More	Preclinical

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